Hobson Prior is currently seeking a Quality Specialist for a leading biologic manufacturer. The successful candidate will represent Quality in client communications and regulatory inspections/audits, and provide mentorship to junior QA colleagues.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• For this role, you will assess and authorize process control strategies and validation protocols/reports.
• Manage deviations, change controls, and investigations related to tech transfer and validation of DS and ADC products.
• Act as Quality representative in client interactions and regulatory inspections/audits.
• Offer guidance and support to junior QA team members.

Requirements

• Demonstrated experience in a GMP manufacturing environment, preferably in a QA role or in a Mfg/MSAT position involving the creation, review, and justification of Quality records.
• Specialized knowledge in ADC processes and submissions.
• Familiarity with ICH, FDA, and EMA guidelines pertaining to process validation, process development, and risk assessments.
• Strong command of the English language.
• Openness to relocating to South Korea with covered expenses for rent and flights.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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